An interventional study of Isolation of circulating tumor cells (CTC) from veinous blood in Lung Neoplasms and Pulmonary Disease, Chronic Obstructive, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 20 sites in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic
This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination with unenhanced (without injection of contrast media) low dose (to limit the effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung cancer (LC).
LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55 years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of false positive that require repeat follow-up and also invasive investigations, but also false negatives with metastatic LC being discovered between screening rounds.
Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on LDCT.
The study will focus on patients at very high risk for lung cancer i.e. smokers and ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).
The study will enroll 600 participants who will undergo three rounds of screening at one year intervals, each round combining search for CTC on a blood sample and LDCT. Each participant will be followed for at least one year after the last screening round
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 683 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk
Biological: Isolation of circulating tumor cells (CTC) from veinous blood
Thirty ml of peripheral blood will be collected in buffered EDTA, maintained at 4°C, and processed within 1 hour for filtration. After blood filtration, the membrane will be gently washed with PBS, disassembled from the filtration module, and allowed to air-dry. The determination of CTC number present on filters will be carried out by combining four color immunofluorescent (anti-pancytokeratins/anti-vimentin/DAPI/anti-CD45) staining and cytomorphological examination after Diff-quick and Mayer Hemalun staining in three spots per patient sample. Imaging of immunofluorescent and cytological staining will be performed at x20 magnification using the automated Ariol system. CTCs are identified by relocating images of immunofluorescent and cytological staining.
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
Time frame: 3 years
Rate of detection of CTC in the whole study population
Time frame: once a year for 3 years
Circulating tumor cells
Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.
Time frame: once a year for 3 years
Time span between detection of CTC and detection of lung cancer with LDCT and vice versa
Time frame: once a year for 3 years
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice